APL-like A Cute Myeloid Leukemia in NPM1-M mutated patients: distinctive features and early vascular events
Official title: Observational Study on APL-like Subset Within NPM1-mutated Acute Myeloid Leukemia: a Distinct Phenotypic Signature Correlating With Early-onset Vascular Complications. ACTIVATE (APL-like aCute Myeloid Leukemia: disTInct Phenotype and Early VAscular complicaTions)
Run by Gruppo Italiano Malattie EMatologiche dell'Adulto · NCT07080970 · Data updated 2026-11-12
This observational study tests whether an APL-like appearance in NPM1-mutated AML can predict early clotting problems and vascular events.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto Academic / other |
| Locations | 1 site (Florence) |
| Status | Recruiting |
| Started | July 2026 |
| Main results expected | December 2027 |
| Study ends | November 2028 |
| Registry record updated | June 22, 2026 |
| Trial ID | NCT07080970 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+ years) with de novo AML, untreated, harboring an NPM1 mutation, and with available immunophenotypic data at diagnosis.
✕Probably not a fit
Patients without NPM1 mutation, without APL-like immunophenotype, or who do not develop early vascular events may not experience a direct benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational study combines retrospective and prospective data to characterize the APL-like subset of NPM1-mutated AML. Researchers will analyze clinical and immune-phenotypic features to define a signature that helps identify this subset at diagnosis. Patients with de novo, untreated AML and confirmed NPM1 mutation will be followed for at least 12 months to observe the incidence of early vascular events. The study will focus on coagulopathy risk and vascular complications as potential early indicators. No interventional treatment is being tested in this observational design.
Why it matters
Potential benefit: If successful, clinicians may better predict and monitor early vascular risks in this AML subset, potentially guiding closer surveillance or tailored management.
How similar studies have gone: Previous work in AML subtypes has shown that immunophenotypic signatures can help predict complications, though the exact APL-like and NPM1-mutated overlap is less established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with de novo AML, untreated, newly diagnosed, according to WHO/ICC 2022 criteria from January 2015 onwards. * Presence of NPM1 mutation. * Availability of immunophenotypic characterization at diagnosis * Age \>= 18 years * Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable) Exclusion Criteria: * No specific exclusion criteria are provided once eligibility criteria are met.
Where it's running
-
SOD Ematologia, Università di Firenze, AOU Careggi
Florence, Italy Recruiting
Study contacts
- Principal investigator: Francesco Mannelli — SOD Ematologia, Università di Firenze, AOU Careggi
- Study coordinator: Paola Fazi
- Email: p.fazi@gimema.it
- Phone: 0670390528
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.